Senior Clinical Trial Manager (CTL) - Oncology
Posted on: October 12, 2021
Senior Clinical Trial Manager (Sr. Clinical Team
Why settle for one thing when you can have everything?
Drug Development gives you the best two-for-one
opportunity for career growth. Who doesn’t want twice
the perks? Working at Covance—one of the
largest FSP CROs—and partnering with one sponsor with a dedicated
therapeutic focus. You can have it all!
to an FSP project, you will
bring your specialized discipline to a core team working directly
with one sponsor. Whether your specialization is in clinical
monitoring, clinical project management, data management,
biometrics or pharmacovigilance, we have an FSP opportunity to match your
area of expertise.
will enjoy the best of both worlds—all the benefits that come along
with our Energizing Purpose, Exceptional People and Extraordinary
Potential combined with working exclusively with one sponsor and
this also comes with the benefit of bringing your strong
therapeutic experience to allow your expertise to shine
FSP model is flexible and scalable. Our teams are collaborative and
proactive – a great place for you to continue honing your
therapeutic skills and growing and excelling in new and exciting
reach is global – extending to 60+ countries making us one of the
largest FSP CROs. No matter where you are located on the globe, we have an FSP
opportunity for you.
Senior Clinical Trial Manager
this role, the selected candidate will be responsible for study
oversight and delivery management (time, budget, quality) at
country level from start up to close out and will be the main point
of contact for internal and external stakeholders.
Essential Job Duties:
Coordinates country cross functional teams and acts as the main
point of contact for a Country with the protocol manager and other
global study team members; Coordinates with other internal roles in
country and site feasibility process, including proposal and
validation of country study targets
Develops country level patient recruitment strategy & risk
mitigation. Coordinates and ensures country level study
enrolment targets and timelines are met; leads problem solving and
resolution efforts including management of risk, contingencies,
issue resolution and escalation to the appropriate
Assessment and set up the of vendors during study start up period
(locally); Investigator Meeting participation and
Ensures data entered in Clinical Trial Managements Systems is
current and complete and access to eDC and vendor systems is
available for the Country and clinical trial site personnel;
Validation of study related materials (i.e. protocol, ICF, patient
Responsible for preparing country specific documents (e.g. global
country specific amendment); Prepares materials for Site
Initiation Visits; responsible for verifying and confirming with
local team eTMF completeness (Country and Site level)
Reviews Site Monitoring visit reports, takes action within the
timelines specified and escalates issues and ensures appropriate
documentation of issues.
Coordination of database locks and query follow up. Ensures
timelines are me; ensure inspection readiness of assigned trials
within country. Provide support to Health Authority
inspection and pre-inspection activities
Coordinates, develops and writes the Corrective Actions /
Preventive Actions (CAPA) and ensures implementation for Country
audit level findings. Drives CAPA review, implementation and
completion; Lead study team meetings locally
Reviewing and approving payments (based on GOA) and manage patient
compensation claims (if applicable); Management of Site
relationships (includes CRO related issues); May conduct Pre-Study
Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs); May
perform site closure activities, including post-close out; May act
as point of contact for Sites; May support preparing submissions to
and obtaining approval from local Health Authorities, Ethics
Committees and other relevant instances.
- Must have a
Bachelor’s Degree with at least 6 years of relevant clinical
be flexible and dependable with a BA, BS, or MS degree.
be capable of handling multiple projects and have good computer
have a working knowledge of GCP/ICH guidelines good interpersonal
experience and demonstrate ability to set priorities.
professionalism communicates effectively and is a good team
Keywords: Labcorp, Detroit , Senior Clinical Trial Manager (CTL) - Oncology, Other , Detroit, Michigan
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